UMBRELLA BRANDING LEGAL, REGULATORY AND COMPLIANCE FORUM ON OVER THE COUNTER DRUGS October 29, 2013 Mark Brian Levine, Associate General Counsel Renuka D. Singh, Senior Counsel

Background What is Umbrella Branding and Why Should We Care?

– Umbrella branding occurs when companies take what used to be just a product name, turn it into a brand name, and then release multiple line extension products under it that differ from the original product

– FDA’s concern is that people associate the new brand name (formerly product name) with certain benefits and assume that any new product that features that same name will also have the same benefits

Trademarks

• A brand is among a company’s most valuable assets

• Trademarks associated with brands identify a good or service and distinguish such from other products or services

• The value of a trademark in a consumer’s eyes is undeniable and indisputable since it identifies products as coming from a known and certain source

• A consumer recognizes a certain trademark and relies on previous experiences with the product and associates the product’s characteristics with the name and reputation of its producer

Trade Names Why are Trade Names so important?

• Goodwill

• Product quality

• General name recognition (enables companies to differentiate themselves from others)

• Monetary investment in a brand / brand development

• Companies wants to leverage the benefits of a trade name and sell a “new” product under the same brand rather than develop a new brand

Questions to Consider:

• What are the challenges in developing a proprietary name to reduce medication errors?

• What are some strategies for addressing these challenges without compromising safety?

• When products are developed containing the same ingredient as a marketed product, how can risks associated with a given nomenclature strategy (i.e. use of a modifier “Proprietary Name ER” versus the use of an alternate proprietary name) for a proposed product be evaluated, assessed, and mitigated?

• When applicants wish to use the same proprietary name for products containing different ingredient(s), how can risks associated with this practice evaluated, assessed, and mitigated?

Brand Name Line Extension

• Brand Name Line Extension (BNLE): Use of a root name across a product

line

• Long-standing practice with OTC products

• BNLE products currently marketed as monograph, NDA, and ANDA

products

• Claritin (loratadine), Claritin-D 24-Hour (loratadine/pseudoephedrine),

Children’s Claritin Grape Chewables (loratadine)

• Zyrtec (cetirizine), Zyrtec-D (ceterizine/pseudoephedrine), Children’s Zyrtec

Allergy Syrup (ceterizine)

Brand Name Line Extension

• Products with the same root name generally share at least one active ingredient

• Umbrella branding: when the same root name is used for products that do NOT share ANY active ingredients with the base brand

– Claritin Eye (ketotifen fumarate)

– Zyrtec Itchy Eye (ketotifen fumarate)

Arguments for Umbrella Branding

– Role of regulatory authority relates to quality, safety, efficacy only

– Lack of evidence that manufacturers’ freedom to choose a particular brand name jeopardizes the safety of the patient in the correct use of medicines

– Names establish trust and quality reputation between the company/product and the consumer

– Umbrella brands allow consumers to navigate therapeutic categories, recognize product families and then select individual products

Arguments for Umbrella Branding

– Umbrella brands create trust – in particular for new products

– Consumers are exposed to/familiar with umbrella brands in all kinds of product categories; not a concept specific to OTC brands

– Building trust and awareness behind entirely new brands is difficult within consumer healthcare

– Requiring distinctly different brand identities for each different ingredient or medical condition could hold back the development of new self medication products or categories of products

– Rapid recognition of familiar brands can greatly aid the consumer and facilitate quick and uncomplicated treatment in these circumstances

Arguments for Umbrella Branding

• Moving to self-diagnosis is making packaging and in-store design increasingly important.

• Over the counter purchasing is all about trust – so strong umbrella brands are essential.

• Efficacy isn’t the only factor in OTC success – you need the emotional connection with consumers to build upon.

• A consumer has to be exposed to a brand repeatedly before he registers it. Umbrella branding allows for a manufacturer to focus resources on driving one brand’s awareness rather than have multiple weak brands.

Why limit umbrella branding? Why does the FDA care?

• Medication Errors

• Use of wrong product

• Administration of unnecessary active ingredient

• Wrong indication

• Wrong patient population

• Likelihood of error and risk of harm may be increased when a name is used for products that do not share at least one active ingredient

WHY LIMIT OTC UMBRELLA BRANDING

– Umbrella Branding for OTC products that contain the same active ingredients, but labeled for different indications may have risk of adverse effects and overdose.

– Names are acceptable if they are not associated with “perceived public health concerns of a safety risk related to the possibility of confusion or to misleading inferences”

– Primary FDA concern is to reduce name confusion, product identification failure (wrong drug) or other potential medication errors (wrong dose or inappropriate dosing)

DICKERSON DOWNING / TRADEMARK PRESENTATION

OTC Trademarks

Dickerson M. Downing

Crowell and Moring

590 Madison Avenue

New York, New York

October 29, 2013

Trademark

Any word name symbol or device that is used to identify and distinguish the goods of the owner from those manufactured and sold by others and to indicate the source of those goods. 15 USC ¶1127

Trademark

• OTC House and Product Mark

• Packaging Trade Dress

• Product Shape Trade Dress

Pharma Names and Marks

Clearance

Tale of Two Hurdles

Tale Of Two Hurdles

Registration

Registration Bars

Consists of a mark which when used on or in connection with the goods of the applicant is merely descriptive or deceptively misdescriptive of them. 15 USC ¶1052(e)

Registration Bars

Consists of or comprises a mark which so resembles a mark registered in the Patent and Trademark Office, … as to be likely … to cause confusion, or to cause mistake, or to deceive. 15 USC ¶1052(d)

Registration Bars

Confusion Analysis

•Similarity of the marks;

•Similarity of the goods

•Strength of Prior Mark

•Conditions of purchase

•Fame of prior mark

•Actual Confusion

Tale of Two Hurdles

Bars To Approval

352. Misbranded drugs and devices

(a) False or misleading label. If its labeling is false or misleading in any particular

Bars To Approval

The employment of a fanciful proprietary name for a drug or ingredient in such a manner as to [falsely] imply that the drug or ingredient has some unique effectiveness or composition

Bars To Approval

Designation of a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient.

FDA Perspective

Drug names, labels and packaging are major contributors to medication errors

PTO Approach

PTO Approach

FDA Approach

FDA Approach

FDA Approach

FDA Approach

Your Mark

Tale of Two Hurdles

• Line Extensions

• Umbrella Brands

• OK with the PTO Approach

• Potentially problematic with the FDA Approach

Tale of Two Hurdles

• Line Extensions

• Umbrella Brands

What do the FDA Labeling

Requirements Have to Do With

Trademark Applications?

Losing Your Place in Line

• 2001: CreAgri begins selling Olivenol, a dietary supplement containing an antioxidant found in olives called hydroxytyrosol but …each tablet sold before contained 3mg while the label claimed 5mg. or 25 mg.

• 21 C.F.R. § 101.9(g)(4)(i) requires the actual amount of a nutrient be "at least equal to the value for that nutrient declared on the label”

• Not a use in commerce for trademark priority purposes

CreAgri, Inc. v. USANA Health Sciences, Inc. 474 F.3d 626 (9th Cir. 2007)

OTC Trademarks

Dickerson M. Downing

Crowell and Moring

590 Madison Avenue

New York, New York

October 29, 2013

US Regulatory and Umbrella Branding

• There is no regulation explicitly prohibiting

• There is no guidance outlining the appropriate use of proprietary names

• Difference in handling OTC monograph vs NDA pre-approval of names

International Concerns – Certain countries have explicit regulatory rules about umbrella branding

– Australia/New Zealand

– Ireland

– Canada

• Products in same therapeutic area with different active substances have been allowed to be promoted under the same brand name

– Germany; additional product descriptors are required and approval of tradenames including an umbrella brand is often granted only after lengthy negotiations with the authorities

– Spain is one of the most restrictive countries with regards to the use of umbrella brand names

Australia

• The OTC application categorisation framework defines the different application levels for applications for new medicines, and changes to existing medicines.

• Within this framework, applications for umbrella brand extensions are identified as “requiring an increased level of assessment when the risks to consumers are considered to be higher.”

Germany

• New rules on umbrella trademarks for medicinal products in Germany

• On 20 March 2013, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) and the Paul Ehrlich Institut (PEI) issued a final set of guidelines for the naming/denomination of medicinal products

• BfArM had started to take a much stricter approach; Applications for umbrella Trademarks were being rejected on the grounds that such concepts were illegal per se when extended to products containing different active ingredients, irrespective of the circumstances of the individual case, disregarding in particular any additional information provided by qualifying elements of the umbrella trademark (annexes) or by the labelling/packaging material.

Germany

• The new rules:

• The strict prohibition of umbrella trademarks for products with different active ingredients has been removed.

• According to Section 2.2.1 of the guidelines, the use of umbrella trademarks to other active substances is to be avoided subject to the provision of misleading denominations under Section 8 AMG because of the potential risk of confusion. This assessment shall be made by reference to the following risk-based principle:

• “The greater the differences in the individual medicinal products and the higher the risk of confusing one medicinal product with another, the more pronounced should be the differences in the name of the medicinal product.”

Germany

• The following list of criteria is also intended to help in the decision-making process:

• area of applications (ATC code/pharmacotherapeutic group)

• patient group/distribution channel/prescribing practices

• type of application

• pharmaceutical form/strength

• prescription status

• range of side effects

Canada

• Canada has guidelines that state that a brand name must be associated with a specific ingredient

• Drug products in Canada will fall under one of two classifications: Natural Health Products and Drugs

• Licenses are granted upon approval of a product, so although Health Canada has no official framework for jurisdiction, their interpretation of the ACT prevails

• The Natural Health Products Directorate and the Therapeutic Products Directorate do not speak so brand names with differing ingredients exist where the products fall under different classifications

Gravol Example -- Canada Supplement and OTC Confusion

EXAMPLES

Benadryl Example

• Benadryl Extra Strength Itch Stopping Gel

• 2010

• 121 adverse event reports between 2001-2009

• Consumers reporting accidental ingestion because of confusion with oral liquid products

• J&J added warning to packaging “for skin use only” but did not change product name

• The FDA received reports about side effects such as unconsciousness, hallucinations, and confusion in the people who had unknowingly swallowed Benadryl Extra Strength Itch Stopping Gel.

• Johnson & Johnson, redesigned its bottle and attached yellow sticker to state that "for skin use" only

Maalox

• FDA warned of the potential side effects for some consumers of Maalox Total Relief (bismuth subsalicylate), indicated for relief from stomachache and diarrhea. Other products in the Maalox line are antacids, including Maalox Advanced Extra Strength

• "Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other," according to Carol Holquist, FDA's director of its Division of Medication Error Prevention and Analysis, in the release.

• "Consumer confusion and incorrect product use due to name confusion are serious public health issues," and "We want companies to consider the potential for name confusion when choosing names for their drugs."

• At FDA’s request, Novartis changed name of product to avoid serious side effects

• FDA noted that the risk was identified through mandatory adverse event reporting

Maalox

Takeaway Questions

– Why is this practice more acceptable under “private label” brands rather than branded products?

– How many well documented cases are there of patient confusion over the name of medicinal products?

– When confusion occurs in the OTC space, aren’t the consequences mostly minor?

– Is there safety data to substantiate that confusion is enhanced by the use of umbrella trade names provided the products are appropriately labeled and sufficient consumer information is made available

– Objective is always the promotion of the correct and safe use of medicine

– Umbrella brands are valuable assets for companies

–Confidence in otc products are enhanced

–Within an umbrella range, all products are endowed with a quality seal

CONCLUSION